On September 3, 2024 NH TherAguix (NHT), a phase II clinical-stage biotechnology company specializing in the development of novel nanomedicine solutions for precision radiotherapy in oncology, reported that the Data Safety and Monitoring Board (DSMB) has validated the continuation of the Phase II trial, NANOBRAINMETS, managed by the Dana Farber Cancer Institute, following the futility analysis scheduled after the enrollment and follow up of 50% of patients in the study (Press release, NH TherAguix, SEP 3, 2024, View Source [SID1234646300]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Ongoing evaluation of the study has revealed no serious adverse events related to the administration of AGuIX, highlighting the very favorable safety profile of this drug candidate. Developed by NH TherAguix, AGuIX is designed to improve tumor targeting and increase radiobiological damage to tumor tissue locally, thanks to its radiation signal amplification capabilities.
96 patients have been randomized up to date on the 134 scheduled in the study’s protocol.
NANOBRAINMETS is a randomized, double-blind Phase II trial evaluating AGuIX in combination with stereotactic radiotherapy in patients with brain metastases, compared with a control arm using stereotactic radiotherapy alone. Next interim analysis is currently expected by the end of this year to assess the clinical efficacy of AGuIX.
Dr. Ayal Aizer, MD, MHS, Director of the Central Nervous System Radiation Oncology Division at the Brigham and Women’s Hospital / Dana-Farber Cancer Institute, principal investigator of the NANOBRAINMETS study said: "We are very pleased to continue this cutting-edge clinical trial, which evaluates a promising new treatment for patients suffering from brain metastases. This study could lead to the development of a new standard of treatment for these devastating cancers, addressing a significant medical need today."
Dr. Olivier de Beaumont, CMO of NH TherAguix said: "We sincerely thank Dr. Aizer and the teams at the Dana-Farber Cancer Institute for constant and fruitful collaboration of more than 10 years of research with NHT team".
Vincent Carrère, CEO of NH TherAguix, added: "This first positive step paves the way for the major next inflexion point expected in the second half of the year regarding the interim efficacy analysis of AGuIX. The Phase II final results expected by Q2-Q3 2026 will be decisive for the further clinical development of AGuIX and its commercial approval for treating these cancers with high medical need."